Kornimate/medical-research-clean huggingface dataset:
green tea and quercetin in combination with docetaxel chemotherapy in castration-resistant prostate cancer patients

Conditions: Metastatic Castration-resistant Prostate Cancer (mCRPC)

Summary: the goal of this clinical trial is to find out if taking natural products green tea and quercetin along with docetaxel chemotherapy improves the therapy of advanced prostate cancer, i.e., metastatic castration-resistant prostate cancer (mcrpc). it will also learn about the safety of this combination. researchers will compare green tea plus quercetin to a placebo (a look-alike substance that contains no drug) in combination with docetaxel to see if green tea and quercetin works to improve the therapeutic effect of docetaxel.


Eligibility criteria:
inclusion criteria: * signed and dated informed consent form and hippa (health insurance portability and accountability act) authorization. * stated willingness to comply with all study procedures and availability for the duration of the study. * male patients 18 years or older * diagnosed with metastatic prostate cancer * history of confirmed progressive disease with concurrent use of medical castration (e.g. luteinizing hormone-releasing hormone analogue), or surgical castration * confirmed progressive disease with concurrent use of enzalutamide, apalutamide, darolutamide, and/or abiraterone acetate * clinical decision to start doc infusion with prednisone treatment * adequate bone marrow function (absolute neutrophil count (anc) more than1500 cells/mm³, platelet count more than 100,000 cells/mm³) * adequate liver function (total bilirubin less than upper limit of normal (uln), alanine aminotransferase (alt) less than 1.5 x uln, aspartate aminotransferase (ast) less than 1.5 x uln) * adequate renal function (serum creatinine level within normal limits) * at least a 6-month or greater life expectancy * willing to stop consuming tea or tea-containing products and quercetin supplements throughout the entire intervention period except for the green tea extract and quercetin provided during study intervention exclusion criteria: * prior treatment of chemotherapy and/or radiotherapy for metastatic disease * any comorbid condition that would preclude the administration of docetaxel/prednisone * ongoing alcohol abuse * significant medical or psychiatric conditions that would make the patient a poor protocol candidate * prior allergic reaction to tea, tea products or quercetin supplements * allergies to multiple food items or nutritional supplements

Keywords: green tea quercetin docetaxel prostate cancer phase ii
impact on ovarian reserve of diode laser vs bipolar coagulation of endometriomas

Conditions: Ovarian Endometrioma

Summary: endometriosis is a benign chronic gynaecological disease that affects 10% of women of reproductive age and takes 40% of them to assisted reproduction techniques. the purpose of the study is to compare the antimüllerian marker (amh) and antral follicular count (afc) , with the most common serological markers of ovarian reserve. the investigators intend to confirm their clinical utility in the assessment of ovarian function, and to promote their use in predicting decreased ovarian reserve. the work therefore moreover arises the objective to validate the bibliographic data about using the laser for haemostasis after stripping endometriomas, to amplify knowledge available in the literature on the surgical treatment of ovarian endometriomas and on the diode laser application in minimally invasive surgery, appraising the trend of afc and amh levels and the possible surgical implications on fertility .


Eligibility criteria:
inclusion criteria: * regular menstrual cycles * unilateral endometrioma greater than 35 mm * no gynecological surgery 3-6 months before surgery * no hormonal therapy 1 month before surgery exclusion criteria: * previous surgery for endometriosis * hormone therapy in the month before the current surgery * coagulation disorders * ongoing pregnancy * pelvic inflammatory disease * malignant disorders * cysts otherwise * gonadotropin-releasing hormone analogues or contraceptive therapy during the follow-up * bmi≥ 30 kg/m2 * endocrinological disorders * unable or unwilling to give written consent

Keywords: laparoscopic surgery diode laser amh afc
a study of oral hymecromone and hyaluronan synthesis

Conditions: Healthy; Respiratory Disease

Summary: the purpose of this study is to add further understanding to the doses of hymecromone that effectively and safely lead to the inhibition of hyaluronan synthesis. in this study we will investigate both circulating hyaluronan in the serum, as well as tissue hyaluronan, using sputum samples as a non-invasive surrogate. this is a parallel, open-label, single-center, dose-response study of hymecromone in healthy adults 18 years of age or older. up to 18 participants will be enrolled. participants will be treated for 4 days with study drug. safety as well as biomarkers of pharmacokinetic and pharmacodynamic response will be monitored during therapy.


Eligibility criteria:
inclusion criteria: * male or female 18-65 years of age * healthy adult with no active medical problems or significant chronic diseases as determined by the study doctor based on history, physical exam * bmi between 18.5 - 30 kg/m2 * taking no medications for at least 1 week before and during study enrollment, including drugs of abuse, prescription or otc medications * male subjects who are heterosexually active must use an acceptable method of contraception (abstinence, condom with or without spermicidal agent, or partner contraceptive use as described in requirements for female subjects) to avoid pregnancy in their partner for the entire study period * female subjects who are heterosexually active must use an acceptable method of contraception: condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, iud, or hormone-based contraceptive * be able to provide written informed consent and comply with requirements of the study * abstinence from alcoholic beverages, caffeinated beverages and orange juice from 3pm the night before a study day until completion of that study day * be able to read, speak and understand english * able and willing to understand the study, adhere to all study procedures, and provide written informed consent exclusion criteria: * subjects with a history of gastrointestinal disease including gastroesophageal reflux disease, gastritis, peptic ulcer disease or dyspepsia * subjects with history of dysphagia, achalasia, or difficulty swallowing capsules, tablets or pills * subjects with liver failure or lfts above the upper limit of normal * subjects with clinically significant elevations in scr, bun or other screening laboratory tests as determined by study physician * subjects with a baseline corrected fridericia's qt interval (qtcf) \>450ms and a baseline ecg abnormalities which in the opinion of the study physician, is clinically significant * subjects with ongoing alcohol or illegal drug use * subjects who are pregnant, lactating or attempting to conceive * known allergy to hymecromone or any component thereof * physician concern that participant may not adhere to the study protocol * current participation in another clinical trial
a trial to evaluate safety and efficacy of rp-l401-0120 in subjects with infantile malignant osteopetrosis

Conditions: Infantile Malignant Osteopetrosis

Summary: the primary objective of this phase 1 study is to evaluate the therapeutic safety and feasibility of the investigational product (ip), rp-l401.

this is a non-randomized phase 1 study to evaluate the preliminary safety and efficacy of hematopoietic gene therapy consisting of autologous cd34+ enriched hematopoietic cells transduced with the lentiviral vector (lv) carrying the human tcirg1 transgene (rp-l401) in pediatric patients with imo. following myeloablative conditioning patients will receive an infusion of the genetically modified hematopoietic stem and progenitor cells (hspcs).

Eligibility criteria:
inclusion criteria: 1. a confirmed diagnosis of imo with documented tcirg1 mutation. 2. age at least 1 month with minimum weight of 4 kg 3. absence of debilitating hydrocephalus (defined as hydrocephalus at nci ctcae v5.0 grade 3 or higher persisting despite shunt or similar procedural intervention). 4. lansky play scale of at least 60% 5. preserved hepatic function (ast/alt ≤3.0 uln; bilirubin ≤1.5 uln; to minimize potential for excessive toxicity from busulfan conditioning) 6. no concomitant medical or other conditions that would represent a contraindication to autologous hematopoietic stem cell transplant. 7. absolute neutrophil count of ≥500/mm3 and platelet count of ≥25,000/mm3 8. no prior allogeneic or other hematopoietic stem cell transplant. 9. availability of a non-autologous rescue (back-up) hematopoietic stem cell donor/source exclusion criteria: 1. availability of medically-feasible hla-matched sibling donor for allogeneic hsct. 2. any medical or other contraindication for either apheresis or autologous transplant as determined by the investigator. 3. participation in another clinical trial with an investigational drug within 14 days before the informed consent signature. participation in observational studies is allowed. 4. active hematologic or solid organ malignancy, not including non-melanoma skin cancer or another carcinoma in situ. 5. uncontrolled seizure disorder. 6. renal dysfunction as defined by a glomerular filtration rate \<30 ml/min/1.73m2 or dialysis dependence. 7. serious infections with persistent bloodstream pathogens at time of trial entry 8. pulmonary dysfunction as defined by either: * need for supplemental oxygen during the prior 2 weeks (in absence of acute infection) or * oxygen saturation (by pulse oximetry) \<90% resulting from pulmonary conditions (intermittent hypoxia secondary to imo-related choanal atresia will not be considered exclusionary)

Keywords: impaired bone resorption deficient osteoclast development autosomal recessive disorder musculoskeletal diseases bone diseases hypocalcemia bone marrow failure
patient education using 3d printed model

Conditions: Ankle Injuries; Fracture, Ankle

Summary: complex high energy fractures of the lower extremity are life changing injuries and are known to be associated with poor functional outcome post operatively. the list of potential post-operative complications associated with these injuries is long, and the worst of these fractures can even be limb threatening. one of the most difficult and prevalent post-operative issues this patient population faces is chronic pain and its association to opioid addiction, which is currently an epidemic across north america. these individuals not only present with physical insult but psychological trauma as well, which also greatly affects these patients post-operatively. properly educating the patient about their injury and the process that they will embark on can greatly empower the patient as they begin their journey of rehabilitation. this process can hopefully mute or silence some of these modifiable risk factors predisposing patients to poor functional outcomes and chronic pain. the investigators also hope to help them initiate/develop coping strategies to better overcome the many obstacles these patients face and to do so using 3d printing. 3d printed models have not only been demonstrated to be valuable in orthopaedics, when it comes to educating patients about their disease and associated interventions, but many other specialties as well; such as: cardiac surgery, urology, and general surgery. literature suggest that often little is understood or retained by the patient following a patient consent with regards to their injury, potential complications, interventions to be undertaken, as well as the rehabilitation process to follow. by providing the patient with a 3d printed model of their fracture while educating them pre-/post-operatively, the investigators hope they will better understand the aforementioned, often forgotten points, indirectly yielding better overall patient satisfaction, patient outcomes and pain scores.


Eligibility criteria:
inclusion criteria: * periarticular injury involving the plafond, calcaneus or talus that requires open reduction and internal fixation * patient must have a completed ct scan as part of their pre-operative planning protocol exclusion criteria: * open fracture * patient with known psychiatric history (depression, borderline personality disorder, bipolar etc) * prior fracture fixation of the same ankle or foot * diabetic neuropathy/charcot foot * dementia or other cognitive comorbidities (ie stroke etc) * no primary address * patient who were not independent mobilizers prior to injury
validating and optimizing model of antipsychotics selection

Conditions: Schizophrenia

Summary: this multi-centre study will evaluate the clinical efficacy of 3 atypical antipsychotics treatment in chinese patients with schizophrenia by comparing model-decision with real-world psychiatrist-decision. the three atypical antipsychotics are olanzapine (5-20 milligram per day), risperidone (2-6 milligram per day) and aripiprazole (5-30 milligram per day). the main purpose of this study is to explore the potential difference between modal-aided-decision with clinician-decision in order to validate and optimize the selection model that has been established in advance. the efficacy evaluations include symptoms, social function, recurrence rate and hospitalization. visits occurs at 0, 4, 8, 13, 26, 52 weeks.


Eligibility criteria:
inclusion criteria: * an in-patient or out-patient (male or female) and aged ≥18 years * a diagnosis of schizophrenia, dsm-5 (diagnostic and statistical manual diploma in social medicine-5) * subjects must have the ability to effectively communicate with investigator, complete study related documents, comprehend the key components of the consent form and must provide written informed consent to participate in the study prior to any study specific assessments or procedures. * patients are taking or will take atypical antipsychotics which include olanzapine, risperidone, aripiprazole. * baseline panss total score ≥70 exclusion criteria: * participation in other clinical studies. * known intolerance or lack of efficacy to olanzapine, risperidone or aripiprazole. * use of clozapine within 28 days prior to randomization. * other conditions which, in the investigator's judgment, render patients unsuitable for the clinical study.
use of acupuncture in children with autistic spectrum disorder

Conditions: Autism; Autistic Disorder

Summary: this is a study of the efficacy of acupuncture in children with autism.

autism spectrum disorder (asd) or autism is a neurodevelopmental disorder with unknown etiology. asd consisted of 3 core features: 1) disorder of language or communication; 2) disorder of social interaction; and 3) obsessive and stereotypic behavior. acupuncture had been practiced in china for over two millennia. in traditional chinese acupuncture, nearly 400 acupoints on the body surface are interrelated to various functions. the approach in tcm, in sharp contrast to western medical concept, was a "holistic" approach with a philosophical background of balancing the "yin-and-yang". the main objective of tcm was to improve health of body and mind by deblocking the flow of "qi" in the body. the pathophysiological basis of tcm aimed to improve "energy" or "body-flow" or "qi" \["de-qui" in chinese\]. the effect of acupuncture was had been proven in animal and human studies to be due to direct neural stimulation, changes in neurotransmitters such as endorphin, immunological markers or endocrinological signals. thus, acupuncture is especially effective in chronic disorders, especially neurological ones. as there is no tcm concept of mental retardation or autism, we propose that asd is part of the spectrum of the tcm concept of the "four delayed syndrome" in children with "delay in motor skills, speech, hair and teeth eruption" according to tcm concept. thus, we approach asd according to tcm concept as part of the lower intelligence due to imbalance of "heart meridian and kidney meridian" (i.e. yin-yang imbalance) resulting in communication problem and "liver meridian" (yin-yang imbalance) leading to behavioral problems. our objective is to use a different approach in looking at asd and to assess the efficacy of tcm model in improving the functional status of these children. specific acupoints corresponding to various organs and meridians were used for asd. the organ and meridian concept in tcm model has been as a fundamental basis to improve the behavior, cognition and communicative ability in children with asd.

Eligibility criteria:
inclusion criteria: * the diagnosis of asd or autism was made according to the criteria of the 4th edition of the diagnostic and statistical manual of mental disorders (dsm-iv) and autism diagnostic interview-revised (adi-r). * the diagnosis of autism was made if it satisfied a score greater than 30 in the childhood autism rating scale (cars). exclusion criteria: * children with associated neurological disorders such as tuberous sclerosis, fragile x syndrome and epilepsy.

Keywords: traditional chinese medicine (tcm) alternative medicine (am) tongue acupuncture (tac) autism spectrum disorder (asd) autism children
periodontal impact of eating disorders (the perioed study)

Conditions: Periodontal Diseases; Eating Disorder; Anorexia Nervosa; Bulimia Nervosa

Summary: this study evaluated the periodontal status of patients suffering from eating disorders (anorexia nervosa and bulimia nervosa). the work hypothesis is that eating disorder patients have a higher risk for periodontal diseases than non-eating disorder subjects.

eating disorders have been associated with poor oral health. however, the relationship between eating disorders and periodontal diseases is less-established. participants will be periodontally assessed using a full-mouth clinical evaluation.

Eligibility criteria:
inclusion criteria: * in and out eating disorder patients * subject with a diagnosis of anorexia nervosa or bulimia nervosa for at least 5 years * subject affiliated to the french social insurance exclusion criteria: * subject who do not speak french * subject who is not able to read and/or understand the information form * subject who take anti-inflammatory medications or antibiotics at dental examination * subject who has received any dental treatment that could interfere with the periodontal status 3 month before the clinical examination (scaling and root planning, orthodontic treatment ongoing) * subject who has less than 10 teeth

Keywords: periodontitis
incidence and risk factors of peri-operative stroke in non-cardiac,non-neurosurgical surgeries

Conditions: Peri-operative Stroke; Perioperative Adverse Events; Non-cardiac Surgery; Non-neurosurgical Surgery

Summary: stroke is an important cause of perioperative morbidity and mortality, particularly in patients \> 60 years. in cardiac, neurological and carotid surgery the incidence is known to be high (2.2-5.2%). however, little is known regarding perioperative stroke following other types of surgery including general, urological, orthopedic, thoracic and gynecological procedures. we therefore propose to undertake a multicenter, observational cohort study, to determine the current incidence of, the risk factors for, and outcome associated with perioperative stroke in patients undergoing non-cardiac and non-neurological surgery.

patient population: prospective cohort study of 10,000 adults undergoing non-cardiac, non-neurological surgery. screening and enrollment: consecutive patients undergoing (elective or emergency) non-cardiac, non-neurosurgical surgeries will be recruited. monitoring, follow-up, and data collection: usual treatment will be provided. demographic details will be recorded. patients will be visited regularly in hospital. patient will be reviewed for neurologic deficit using the mnihss. brain imaging will be performed to confirm stroke event. follow-up at 30 days after discharge will be done to ascertain if there is any adverse outcome.

Eligibility criteria:
inclusion criteria: * ages eligible for study: 60 years and older * genders eligible for study: both * accepts healthy volunteers: no * sampling method: probability sample exclusion criteria: * hospital stay after surgery less than 3 days * not consent of the assessment * surgery canceled

Keywords: peri-operative stroke incidence risk factors prospective
prevalence of ncd risk factors in kazakhstan

Conditions: Non-Communicable Chronic Diseases

Summary: this is a cross-sectional study that aims to study the prevalence of risk factors of noncommunicable diseases in people aged 18 to 69 years using the standardized and adopted steps questionnaire in the republic of kazakhstan.

the who stepwise approach to ncd risk factor surveillance (steps) is a simple, standardized method for collecting, analysing and disseminating data on key ncd risk factors in countries. the survey instrument covers key behavioral risk factors: tobacco use, alcohol consumption, physical activity, unhealthy diet, as well as key biological risk factors: overweight and obesity, raised blood pressure, raised blood glucose, and abnormal blood lipids.

Eligibility criteria:
inclusion criteria: * age limits 18-69 years